Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time

University of Kansas

Status: Enrolling

Conditions: Inclusion Body Myositis

Treatments: Device: PAMSys pendant PAMSys wrist sensors

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06153108

Biosensics IBM

Details and patient eligibility

About

Inclusion-Body Myositis (IBM) results in weakness and the deterioration of distal arm muscles, the symptoms of which are currently assessed through expert examination at clinical visits. Such in-clinic assessments are time-consuming, subjective, of limited sensitivity, and only provide a snapshot of a patient's disease. In this project, the investigators will conduct clinical validation of monitoring digital biomarkers of upper limb function during activities of daily living using a wearable sensor platform that enables frequent, at-home monitoring of upper limb function health in IBM and could be incorporated into IBM trials.

Enrollment: 20 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet any of the European Neuromuscular Centre Inclusion Body Myositis research diagnostic criteria 2011 categories for IBM.
2. Able to provide informed consent.

Exclusion criteria

1. Unwillingness to follow study procedures.
2. Participation in an investigational drug research study within the past 30 days.